中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500098432
最近更新日期： Date of Last Refreshed on：	2025-03-07 15:01:43
注册时间： Date of Registration：	2025-03-07 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	布地奈德福莫特罗吸入气雾剂在健康受试者中的单剂量、空腹、随机、开放生物等效性研究
Public title：	Single dose, fasting, randomized, open label bioequivalence study of budesonide fomotro inhaled aerosol in healthy subjects
注册题目简写：
English Acronym：
研究课题的正式科学名称：	布地奈德福莫特罗吸入气雾剂在健康受试者中的单剂量、空腹、随机、开放生物等效性研究
Scientific title：	Single dose, fasting, randomized, open label bioequivalence study of budesonide fomotro inhaled aerosol in healthy subjects
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	李银娟	研究负责人：	王兴河
Applicant：	Li Yinjuan	Study leader：	Wang Xinghe
申请注册联系人电话： Applicant telephone：	+86 10 6392 6402	研究负责人电话： Study leader's telephone：	+86 10 6392 6401
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	liyinjuan@126.com	研究负责人电子邮件： Study leader's E-mail：	wangxh@bjsjth.cn
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	北京市海淀区羊坊店铁医路10号	研究负责人通讯地址：	北京市海淀区羊坊店铁医路10号
Applicant address：	10 Tieyi Road, Yangfangdian, Haidian District, Beijing, China	Study leader's address：	10 Tieyi Road, Yangfangdian, Haidian District, Beijing, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	首都医科大学附属北京世纪坛医院
Applicant's institution：	Beijing Shijitan Hospital, Capital Medical University
研究负责人所在单位：	首都医科大学附属北京世纪坛医院
Affiliation of the Leader：	Beijing Shijitan Hospital, Capital Medical University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	(2021)伦审第(5)号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	首都医科大学附属北京世纪坛医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Beijing Shijitan Hospital, Capital Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2021-01-28 00:00:00
伦理委员会联系人：	李继红
Contact Name of the ethic committee：	Li jihong
伦理委员会联系地址：	北京市海淀区羊坊店铁医路10号
Contact Address of the ethic committee：	10 Tieyi Road, Yangfangdian, Haidian District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 6392 6342	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

首都医科大学附属北京世纪坛医院

Primary sponsor：

Beijing Shijitan Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市海淀区羊坊店铁医路10号

Primary sponsor's address：

10 Tieyi Road, Yangfangdian, Haidian District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	四川	市(区县)：	成都
Country：	China	Province：	Sichuan	City：	chengdu
单位(医院)：	四川普锐特药业有限公司	具体地址：	高新区高朋大道15号
Institution hospital：	Sichuan Purity Pharmaceutical Co., Ltd.	Address：	15 Gaopeng Avenue, High-Tech Zone

经费或物资来源：

四川普锐特药业有限公司

Source(s) of funding：

Sichuan Purity Pharmaceutical Co., Ltd.

研究疾病：

慢性阻塞性肺疾病

Target disease：

chronic obstructive pulmonary disease

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

随机交叉对照

Study design：

Cross-over

研究目的：

主要研究目的：以四川普锐特药业有限公司生产的布地奈德福莫特罗吸入气雾剂为受试制剂，原研ASTRAZENECA公司生产的布地奈德福莫特罗吸入气雾剂（商品名：SYMBICORT®）为参比制剂，评价受试制剂和参比制剂在空腹、非炭阻断条件下给药时的生物等效性。次要研究目的：考察布地奈德福莫特罗吸入气雾剂在健康受试者中的安全性。

Objectives of Study：

Main research purposes: Take the budesonide formoterol inhalation aerosol produced by Sichuan Primet Pharmaceutical Co., Ltd. as the test preparation, and the original budesonide formoterol inhalation aerosol produced by ASTRAZENECA Co., Ltd. (trade name: SYMBOLICORT ®) Evaluate the bioequivalence of the test and reference formulations under fasting and non charcoal blocking conditions as reference formulations. Secondary research objective: To investigate the safety of budesonide and formoterol inhaled aerosols in healthy subjects.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1、对布地奈德福莫特罗吸入气雾剂及其相关化合物和辅料中任何成份过敏者，或对两种或两种以上药物（或食物）过敏者； 2、不能遵守统一饮食（如对标准餐食物不耐受等）者； 3、不能耐受静脉穿刺者，有晕针晕血史者； 4、筛选前14天内有新冠肺炎疫区居住、旅游史及与新冠肺炎确诊或疑似患者有密切接触史者； 5、存在研究者判断为有临床意义的心血管、肝脏、肾脏、内分泌、代谢、消化道、血液系统、呼吸系统、感染、恶性肿瘤、精神异常等病史或现有上述疾病者； 6、既往有甲状腺功能亢进病史或筛选期甲状腺功能检查异常有临床意义者； 7、在筛选前6个月内接受过重大外科手术者，或者计划在研究期间进行手术者，及凡接受过会影响药物吸收、分布、代谢、排泄的手术者（阑尾炎手术除外）； 8、有哮喘病史或气道高反应者； 9、存在活动性或非活动性肺结核感染，未加治疗的全身性真菌、细菌、病毒或寄生虫感染，或眼部单纯疱疹者； 10、既往或现患有青光眼、白内障者； 11、正在患有口腔疾病者（如口腔溃疡、口腔黏膜破损等）； 12、筛选期体格检查、生命体征监测、心电图检查、胸部CT、肺功能检查、实验室检查（血常规、尿常规、血生化、凝血功能等），研究者判断异常有临床意义者； 13、乙肝表面抗原、丙肝抗体、梅毒螺旋体抗体或艾滋病病毒抗体检查结果异常有临床意义者； 14、既往长期（筛选前3个月内）饮用过量（一天8杯以上，1杯=200mL）茶、咖啡或含咖啡因的饮料者；或研究首次用药前48小时内，摄入任何含有咖啡因的食物或饮料（如咖啡、浓茶、巧克力等）者； 15、研究首次用药前48小时内，摄入过任何富含黄嘌呤或葡萄柚成分或其他影响药物吸收、分布、代谢、排泄等的饮料或食物者； 16、筛选前4周内使用过任何与布地奈德、福莫特罗有相互作用的药物（如CYP3A4抑制剂（如酮康唑、伊曲康唑、克拉霉素、红霉素等）、单胺氧化酶抑制剂及相似特性的药物（如呋喃唑酮和丙卡巴肼）、三环类抗抑郁药、β-肾上腺素受体阻滞剂（包括滴眼剂）、其他β-肾上腺素受体激动剂、抗组胺药、利尿剂等）； 17、试验前6个月内使用过长效雌激素或孕激素注射剂或埋植片者；试验前30天内使用过短效避孕药者； 18、研究首次用药前14天内使用过任何处方药、非处方药、中草药、保健品者； 19、筛选前3个月每日吸烟量多于5支者，或研究首次用药前烟检阳性者以及入选后至整个试验期间不能接受禁止吸烟者； 20、研究首次用药前酒精呼气检测结果阳性，或筛选前6个月内每周饮酒超过14个标准单位（1标准单位含14g酒精，如360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）； 21、研究首次用药前药物滥用尿液筛查结果阳性或筛选前1年内有药物滥用史（如大麻、苯二氮卓、氯胺酮、吗啡、可卡因、甲基安非他明）者； 22、妊娠或哺乳期妇女或血妊娠检查结果阳性者，以及在整个试验期间及研究结束后3个月内有妊娠计划的男性受试者（或其伴侣）或女性受试者； 23、研究首次用药前3个月内参加了其他临床试验且服用了研究药物者； 24、研究首次用药前3个月内献血或失血>=400mL，或计划在研究期间或研究结束后3个月内献血或血液成分者； 25、研究者认为受试者存在任何其他不适宜参加试验的情况。

Exclusion criteria：

1. Those who are allergic to budesonide formoterol inhalation aerosol and any of its related compounds and excipients, or allergic to two or more drugs (or food); 2. Those who cannot comply with a uniform diet (such as intolerance to standard meals, etc.); 3. Those who cannot tolerate venipuncture, and those who have a history of dizziness and blood sickness; 4. Those who have a history of residence or travel in the epidemic area and a history of close contact with confirmed or suspected patients within 14 days before screening; 5. Those who have a history of cardiovascular, liver, kidney, endocrine, metabolic, digestive tract, blood system, respiratory system, infection, malignant tumor, mental abnormality and other diseases judged by the investigator to be clinically significant, or those who have the above diseases; 6. Those who have a history of hyperthyroidism in the past or abnormal thyroid function tests during the screening period and are clinically significant; 7. Those who have undergone major surgical operations within 6 months before screening, or those who plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs (except for appendicitis surgery); 8. Those with a history of asthma or airway hyperresponsiveness; 9. Patients with active or inactive pulmonary tuberculosis infection, untreated systemic fungal, bacterial, viral or parasitic infection, or ocular herpes simplex; 10. Those who have suffered from glaucoma and cataract in the past or now; 11. Those who are suffering from oral diseases (such as oral ulcers, oral mucosal damage, etc.); 12. During the screening period, physical examination, vital signs monitoring, electrocardiogram examination, chest CT, pulmonary function test, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, etc.), and the investigator judged that the abnormality is clinically significant; 13. Patients with abnormal test results of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or HIV antibody with clinical significance; 14. Those who have drunk excessive amounts of tea, coffee or caffeinated beverages for a long time (more than 8 cups a day, 1 cup = 200mL) for a long time (within 3 months before screening) in the past; or those who have ingested any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose of the study; 15. Those who have ingested any beverage or food rich in xanthine or grapefruit or other substances that affect the absorption, distribution, metabolism, and excretion of drugs within 48 hours before the first dose of the study; 16. Have used any drugs that interact with budesonide and formoterol (such as CYP3A4 inhibitors (such as ketoconazole, itraconazole, clarithromycin, erythromycin, etc.), monoamine oxidase inhibitors and drugs with similar characteristics (such as furazolidone and procarbazine), tricyclic antidepressants, β-adrenergic receptor blockers (including eye drops), other β-adrenergic receptor agonists, antihistamines, diuretics, etc.); 17. Those who have used long-acting estrogen or progesterone injections or implanted tablets within 6 months before the test; Those who have used short-acting contraceptives within 30 days before the trial; 18. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health care products within 14 days before the first dose of the study; 19. Those who smoke more than 5 cigarettes per day in the 3 months before screening, or those who have a positive smoking test before the first dose of the study, and those who cannot accept smoking prohibition after selection and the whole trial period; 20. Positive alcohol breath test result before the first dose of the study, or drinking more than 14 standard units of alcohol per week within 6 months before screening (1 standard unit contains 14g of alcohol, such as 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine); 21. Those who have a positive urine screening result of drug abuse before the first drug use of the study or a history of drug abuse (such as marijuana, benzodiazepines, ketamine, morphine, cocaine, methamphetamine) within 1 year before screening; 22. Pregnant or lactating women or those with positive blood pregnancy test results, as well as male subjects (or their partners) or female subjects who have pregnancy plans during the whole trial period and within 3 months after the end of the study; 23. Those who have participated in other clinical trials and taken the study drug within 3 months before the first dose of the study; 24. Those who donate blood or lose blood >=400mL within 3 months before the first dose of the study, or plan to donate blood or blood components during the study period or within 3 months after the end of the study; 25. The investigator believes that the subject has any other situation that is not suitable for participating in the trial.

研究实施时间：

Study execute time：

从 From 2021-05-07 00:00:00至 To 2021-06-03 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-05-07 00:00:00 至 To 2021-05-15 00:00:00

干预措施：

Interventions：

组别：	A组	样本量：	20
Group：	group A	Sample size：	20
干预措施：	T-R-T-R 受试制剂（T）：布地奈德福莫特罗吸入气雾剂，规格为每揿主药含量：以阀门外计，每瓶120揿，每揿含布地奈德181μg，富马酸福莫特罗5.1μg；递送剂量：以驱动器外计，每瓶120揿，每揿含布地奈德160μg，富马酸福莫特罗4.5μg。由四川普锐特药业有限公司生产和提供。参比制剂（R）：布地奈德福莫特罗吸入气雾剂（商品名：SYMBICORT?），规格为每瓶120揿，以阀门外计，每揿含布地奈德181μg，富马酸福莫特罗5.1μg；以驱动器外计，每揿含布地奈德160μg，富马酸福莫特罗4.5μg。由AstraZeneca公司生产，由四川普锐特药业有限公司提供。	干预措施代码：
Intervention：	T-R-T-R Test preparation (T): budesonide formoterol inhalation aerosol, the specification is the main drug content per bottle: 120 bottles per bottle, 181 μg of budesonide per bottle, 5.1 μg of formoterol fumarate, delivery dose: 120 bottles per bottle, 160 μg of budesonide per bottle, 4.5 μg of formoterol fumarate. Produced and supplied by Sichuan Pritech Pharmaceutical Co., Ltd. Reference preparation (R): budesonide formoterol inhalation aerosol (trade name: SYMBICORT?), specification is 120 puffs per bottle, each puff contains budesonide 181 μg, formoterol fumarate 5.1 μg, and 160 μg of budesonide and 4.5 μg of formoterol fumarate per pinch outside the driver. Produced by AstraZeneca and supplied by Sichuan Pritech Pharmaceutical Co., Ltd.	Intervention code：

组别：	B组	样本量：	20
Group：	group B	Sample size：	20
干预措施：	R-T-R-T 受试制剂（T）：布地奈德福莫特罗吸入气雾剂，规格为每揿主药含量：以阀门外计，每瓶120揿，每揿含布地奈德181μg，富马酸福莫特罗5.1μg；递送剂量：以驱动器外计，每瓶120揿，每揿含布地奈德160μg，富马酸福莫特罗4.5μg。由四川普锐特药业有限公司生产和提供。参比制剂（R）：布地奈德福莫特罗吸入气雾剂（商品名：SYMBICORT?），规格为每瓶120揿，以阀门外计，每揿含布地奈德181μg，富马酸福莫特罗5.1μg；以驱动器外计，每揿含布地奈德160μg，富马酸福莫特罗4.5μg。由AstraZeneca公司生产，由四川普锐特药业有限公司提供。	干预措施代码：
Intervention：	R-T-R-T Test preparation (T): budesonide formoterol inhalation aerosol, the specification is the main drug content per bottle: 120 bottles per bottle, 181 μg of budesonide per bottle, 5.1 μg of formoterol fumarate, delivery dose: 120 bottles per bottle, 160 μg of budesonide per bottle, 4.5 μg of formoterol fumarate. Produced and supplied by Sichuan Pritech Pharmaceutical Co., Ltd. Reference preparation (R): budesonide formoterol inhalation aerosol (trade name: SYMBICORT?), specification is 120 puffs per bottle, each puff contains budesonide 181 μg, formoterol fumarate 5.1 μg, and 160 μg of budesonide and 4.5 μg of formoterol fumarate per pinch outside the driver. Produced by AstraZeneca and supplied by Sichuan Pritech Pharmaceutical Co., Ltd.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京世纪坛医院	单位级别：	三甲
Institution hospital：	Beijing Shijitan Hospital Capital Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	药代动力学参数	指标类型：	主要指标
Outcome：	AUC0-t, AUC0-∞, Cmax, t1/2, λz, Tmax and AUC_%Extrap	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性指标：不良事件、生命体征、体格检查、心电图、实验室检查	指标类型：	次要指标
Outcome：	Safety index: Adverse events, Vital signs, Physical examination, ECG, Laboratory examination	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

按照受试者筛先后顺序依次入组进行随机后被分配唯一的受试者编号。由统计师按照受试者编号将受试者按照1:1 比例随机分配到 2 个给药序列（A或B）之一。

Randomization Procedure (please state who generates the random number sequence and by what method)：

According to the screening order of the subjects, they were randomly assigned a unique subject number. The statistician randomly assigned the subjects to one of two dosing sequences (A or B) in a 1:1 ratio based on their subject numbers.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	开放
Blinding：	open-label

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	试验完成后6个月通过resman共享原始数据, http://www.medresman.org.cn。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Sharing raw data through resman 6 months after the completion of the tria, http://www.medresman.org.cn.
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	数据包括原始记录、病例记录表，采用专用数据库进行数据管理工作
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The data including the original record and CRF. Using private database for data management.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-03-07 15:00:04